Calcium Electroporation in Patients With Barrett's Esophagus High-grade Dysplasia
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Registration of treatment related side effects assessed by CTCAE V 5.0
研究概览
简要总结
The aim of this first-in-man study is to evaluate the safety of calcium electroporation used in patients with Barrett's esophagus high-grade dysplasia through an endoscopic system.
详细描述
After being informed about the study and potential risks, all patients give written informed consent. Thereafter, patient will get calcium electroporation with biopsies and digital photographs on day 0. We expect to discharge all patients same evening. Between day 3-7 an examination is followed by gastroscopy with biopsies and digital photographs. On day 14 the patients are followed in our outpatient clinic. 6 weeks after treatment the patients will undergo endoscopic mucosa resection (EMR) or endoscopic submucosa dissection (ESD) surgery and thereby the standard care of treatment for Barrett's esophagus high-grade dysplasia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18 years old.
- •Histological verified Barrett's esophagus high-grade dysplasia (BE HGD)
- •Expected survival > 3 months.
- •Performance status Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) ≤
- •Platelets ≥ 50 billion/l, International Normalized Ratio (INR) < 1.
- •Medical correction is allowed, e.g. correction of a high International Normalized Ratio (INR) using vitamin K.
- •Subjects must be willing and able to comply with the procedure, such as agreed follow-up visits.
- •Sexually active men and fertile women must use adequate contraception during this trial
- •Subjects must give written informed consent.
排除标准
- •Coagulation disorder that cannot be corrected.
- •Subjects with a clinically significant cardiac arrhythmia.
- •Concurrent treatment with an investigational medicinal product
- •Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.
- •Pregnancy or lactation
- •A medical doctor will always be responsible for final inclusion of the subject.
结局指标
主要结局
Registration of treatment related side effects assessed by CTCAE V 5.0
时间窗: Day 0 to 6 weeks after treatment
This is part of a safety evaluation and will be registered by CTCAE into Adverse Events (AE) and Serious Adverse Events (SAE)
Registration of treatment related pain through a Visual Analogue Score (VAS)
时间窗: Day 0 to 6 weeks after treatment
Second part of safety evaluation which will be registered by VAS score. The VAS score is a scale with values from 0-10, where 0 is no pain and 10 is the worst possible pain.
次要结局
- The rate of patient's that have gained from the treatment(Day 0 to 6 weeks after treatment)
研究者
Michael Patrick Achiam
Consultant, MD, DMSci, Ph.D., FEBS-OG, Ass. Professor
Rigshospitalet, Denmark